NCT05418894

Mapping and Modulating the Spatiotemporal Dynamics of Socio-Affective Processing

StatusEnrolling by Invitation

PhaseNot applicable

SponsorBaylor College of Medicine

Primary completionMar 31, 2031 (estimated)

At risk: Primary completion moved 4 years later.

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Record History

All 6 versions: 3 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 9, 2026 Primary and study completion pushed from Mar 31, 2027 to Mar 31, 2031 Show 4 more changesShow less
- Eligibility criteria expanded, about 37 words
- Trial status changed: Recruiting → Enrolling by Invitation
- Secondary endpoints: details revised at 1 of 3 entries
- Site details revised
Notable Jun 16, 2022 Primary endpoints revised (2)
- Secondary endpoints revised (3)
v2
Jun 10, 2022 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Number of streamlines connecting between intracranial stimulation volume and recording volumes.

Timeframe: up to 8 weeks

Evoked potentials arising from stimulation.

Timeframe: up to 8 weeks

Secondary (3)

Spectral band power during mood-relevant cognitive task.

Spectral band power following applied stimulation.

Match score between spectral band power matrix of desired state and stimulation-evoked state.

Arms and interventions

EMUNo intervention

Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit

TRDExperimental

Devices: Device: Directional Deep Brain Stimulation

Sites

1 site in 1 country

Baylor College of MedicineHouston, Texas, United States

About this trial

The overall goal of this study is to map the spatiotemporal dynamics of social affective processing and to examine selective modulation of these dynamics in humans undergoing invasive intracranial monitoring for treatment-resistant epilepsy and depression. Pursuing this signal from a novel platform with invasive intracranial recording electrodes provides much-needed spatial and temporal resolution to characterize the neural dynamics of socio-affective processing. The investigators will leverage first-in-human intracranial neural recording opportunities created by a novel therapeutic platform termed "stereotactic electroencephalography-informed deep brain stimulation" (stereo-EEG-informed DBS), as well as the powerful platform of intracranial stereotactic recording and stimulation in patients undergoing epilepsy surgical evaluation at Baylor College of Medicine. The sEEG-informed DBS trial provides unique opportunities for intracranial recording of affect-relevant network regions in patients with treatment-resistant depression (TRD). Recordings in identical regions in epilepsy patients who themselves often demonstrate mild-moderate depressive symptoms will provide a wide dynamic range across the symptom spectrum. To provide critical data on the spatiotemporal dynamics of socio-affective processing the investigators will leverage these two human intracranial recording and stimulation cohorts to study the precise structural, functional, and causal properties of the affective salience network. Greater understanding of the social processing circuitry mediated by the affective salience network may be used to drive therapeutic innovation, pioneering a new paradigm that improves socio-emotional function across a wide variety of neuropsychiatric conditions. The results from this proposal have the potential to improve the lives of patients with dysfunction in social affective processing, with implications for a wide range of neuropsychiatric diseases.

Trial details

Enrollment: 84 participants (estimated)
Started: Apr 1, 2022
Study completion: Mar 31, 2031 (estimated)
Eligibility: 22 to 70, all sexes, healthy volunteers accepted
Design: Interventional, non-randomized, open label, basic science
Oversight: Data monitoring committee, FDA-regulated device
Conditions: Depressive Disorder, Treatment-Resistant, Epilepsy, Treatment Resistant Depression
First posted: Jun 14, 2022
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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